Stop Retinal Ganglion Cell Dysfunction Study (STOP-RGCD)

November 17, 2023 updated by: Vittorio Porciatti, University of Miami
Glaucoma is a progressive disease resulting in blindness. Determining the onset of the disease, predicting its severity and the benefit of pressure lowering eye drops is key to clinical management aimed at maintaining useful vision with advancing age. This study will longitudinally monitor a population of glaucoma suspects (with positive factors for the disease but with normal vision) with noninvasive pattern electroretinogram (PERG) and other standard eye tests for glaucoma. The PERG measures the function of retinal ganglion cells (RGCs) that are the parent neurons of the optic nerve. RGCs may become dysfunctional before dying and their function restored with pressure-lowering eye drops. Glaucoma suspects with abnormal PERG will be randomized to treatment with eye drops, while those with normal PERG will be left untreated. All patients will be monitored with PERG, Optic Coherence Tomography (OCT) and other ancillary tests every 6 months over 4 years.

Study Overview

Detailed Description

The PERG is recorded from small metallic buttons taped on the skin similarly to an electrocardiogram, with the difference that the electrodes are around the eyes.

The only physical contact you will experience is a gentle cleaning of the skin with an alcohol prep pad. During the test you must look with both eyes at a Television (TV) display for about 3 minutes. During the follow up period you may be asked to take one more PERG test lying down in a bed.

This will cause a momentary increase of your eye pressure similar to the one that occurs during your normal sleep. This may help to understand whether or not your optic nerve functions normally when the pressure in your eye increases. For OCT evaluation, the pupil has to be dilated with drops as you did before for your eye exam. You have to briefly look at a mark inside the instrument one eye at a time.

PERG and OCT will be performed during the same day of your visit with the eye doctor. If you have already done these tests in the past, as part of another study or as part of your standard treatment, the results of these tests will be obtained from your record, and be included in this study.

If you are a participant in the Observation Group, you will be monitored with PERG, OCT, and standard clinical examinations every six months until close of study. If you are a participant in the Medication Group you will be also treated with eye drop medicines.

RISKS:

There are certain risks and discomforts that may be associated with this research. You should be aware that you are at risk of developing glaucoma whether you participate in the study or not. It is not known whether the risk of developing glaucoma is reduced by eye drops to lower eye pressure; the study will attempt to answer this question.

For the PERG, the only significant risk to you is a small chance of a rash to the cleansing agent for skin electrodes, which should go away without treatment. For OCT, there is a rare risk to you of an allergic reaction to the drops used to dilate your pupils. The risk is even lower if you did not have any reaction during your previous eye exams. In case of an allergic reaction, your eye doctor will immediately treat it. If you had previous problems with pupil dilation, you may wish to speak to your eye doctor about the option of doing this additional test.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Miami, Florida, United States, 33136
        • Bascom Palmer Eye Institute - University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age 18 to 85 years, inclusive
  2. Refractive errors within -5 to +3 diopters
  3. Best corrected visual acuity (BCVA) better than or equal to 20/30 (Snellen)
  4. Normal standard automated perimetry (SAP) according to the Ocular Hypertension Treatment Study (OHTS) criteria15 (reliability < 15% on all indices, normality > 5% on all global indices in two consecutive sessions 6 months apart)
  5. Minimum untreated Intraocular pressure IOP of 15 mm Hg
  6. Glaucoma Suspect Status defined as one or more of the following:

    • Glaucomatous optic disc appearance (vertical cup-to-disc ratio [C/D] ≥0.5
    • Cup disc ratio asymmetry ≥0.2
    • Localized thinning of the disc
    • Presence or history of splinter disc hemorrhage
    • Moderately increased IOP (>21 to <28 mm Hg).
    • Family history of vision loss for glaucoma

Exclusion Criteria:

  1. Age-related macular degeneration
  2. Diabetes
  3. Parkinson's disease
  4. Multiple sclerosis
  5. Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits.
  6. Pregnant or nursing women.
  7. Currently using prescribed pressure lowering medicines and unwilling to be withdrawn from them.
  8. An OHTS risk score high enough in the judgment of the ophthalmologist or optometrist managing the patient to recommend pressure lowering medicine to the patient and not randomization.
  9. An OCT abnormal enough in a pattern consistent with glaucoma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Abnormal PERG Untreated
Participants recognized as Glaucoma suspects with an abnormal PERG test who have been assigned to not receive therapy or intervention.
Experimental: Abnormal PERG Treated

Participants recognized as Glaucoma suspects with an abnormal PERG test who have been assigned to receive one or more drops in each eye in order to reduce the intraocular pressure by 20%.

Drugs could be:

Latanoprost 1 drop Once a day (QD) Bimatoprost 1 drop QD Travoprost 1 drop QD Timolol 1 drop Twice a day (BID) Dorzolamide 1 drop Three times a day (TID) Brinzolamide 1 drop BID Acetazolamide and Methazolamide depends on clinicians evaluation.

If Clinicians consider necessary, he/she might combine 2 drugs in order to get the desired intraocular pressure.

Lower intraocular pressure (IOP) by increasing outflow of fluid from the eye.
Other Names:
  • Xalatan
Lower intraocular pressure by increasing outflow of fluid from the eye.
Other Names:
  • Lumigan
Lower intraocular pressure by increasing outflow of fluid from the eye.
Other Names:
  • Travatan
Lower intraocular pressure by decreasing production of fluid
Other Names:
  • Timoptic
Lowers intraocular pressure by decreasing intraocular fluid production
Other Names:
  • Trusopt
Lowers intraocular pressure by decreasing intraocular fluid production
Other Names:
  • Azopt
Lowers intraocular pressure by decreasing intraocular fluid production
Other Names:
  • Diamox
Lowers intraocular pressure by decreasing intraocular fluid production
Other Names:
  • Neptazane
No Intervention: Normal
Patients with a normal PERG test that will go through the study under observation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in retinal nerve fiber layer thickness
Time Frame: Baseline, 4 years
As measured by Optical Coherence Tomography
Baseline, 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pattern Electroretinogram Amplitude
Time Frame: Baseline, 4 years
Assessed via Pattern Electroretinogram in microvolts
Baseline, 4 years
Change in Pattern Electroretinogram Phase
Time Frame: Baseline, 4 years
Assessed via Pattern Electroretinogram in degrees
Baseline, 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Vittorio Porciattti, DSc, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

March 10, 2015

First Submitted That Met QC Criteria

March 16, 2015

First Posted (Estimated)

March 17, 2015

Study Record Updates

Last Update Posted (Actual)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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